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Sacubitril/Valsartan Versus Valsartan in Heart Failure

Phase 4
Completed
Conditions
Heart Failure
Interventions
Registration Number
NCT05881720
Lead Sponsor
Damanhour University
Brief Summary

The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.

Detailed Description

Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Patients with HF were enrolled if aged > 35 years,
  • Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) < 35%,
  • NYHA class II-III,
  • Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.
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Exclusion Criteria
  • Patients with acute decompensation,
  • Cerebrovascular events during the previous 6 months,
  • Pregnancy, breastfeeding,
  • Any valve dysfunction/abnormality,
  • Active myocarditis,
  • Second-degree and third-degree atrioventricular block,
  • Sick sinus syndrome.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group 1 (N = 40)Sacubitril / Valsartan Oral TabletGroup 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
Group 2 (N = 40)Valsartan 80 mggroup 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Primary Outcome Measures
NameTimeMethod
LVEF %6 months

left ventricular ejection fraction percent

Lipo A (pg/ml)6 months

Lipo protien A (pg/ml)

Troponin.I (ng/ml)6 months

Troponin.I (ng/ml) biomarker

NT-Pro BNP6 months

NT-pro BNP(pg/ml) biomarker

Neopterin (nmol/l)6 Months

Neopterin biomarker

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tanta University Hospital

🇪🇬

Tanta, Elgarbia, Egypt

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